Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy

N/AWithdrawnNCT01961388

Bayer

Overview

The study is designed as non interventional to collect data on the effectiveness of acarbose and metformin monotherapy, respectively, in terms of change from baseline in post prandial blood glucose level at the end of 16 weeks in drug-naïve type 2 diabetic patients within each carbohydrates consumption subgroup under real-life treatment condition in large sample of type-2 diabetes patients in India. The study will begin after the study approval by ethics committee.All drug naïve patients in whom decision to administer acarbose or metformin monotherapy for type 2 diabetes management has been made will be included in study after taking the informed consent.Patients will be observed for up to 16 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose , 24 hr dietary recall etc. The study is planned to enroll 12250 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus

Interventions

Bay G5421 GlucobayDRUG

Oral, dosage of Acarbose as per the directions of treating physician

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Drug-naïve (i.e., the patients should never be treated with anti-diabetic drugs before screening) patients in whom decision to administer monotherapy with either acarbose or metformin for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and medical patient needs, and who consent to participate in study will be included Exclusion Criteria: * Patients receiving any anti-diabetic medication at the time of enrollment in the study will be excluded. However, during observation period, patients may receive any additional anti-diabetics medication at the decision of investigator. * Exclusion criteria should be read in conjunction with local product information. All contra-indications according to the local marketing authorization should be considered

Outcomes

Primary Outcomes

The mean change in post-meal glucose levels from baseline at the end of observation period of up to 16 weeks

The primary outcome will be summarized separately in acarbose and metformin monotherapy treated patients having carbohydrates consumption (National Institute of Nutrition (NIN), India recommend50% to 60% of total calories from carbohydrates in balance diet : - Below NIN recommendation (\< 50%) - As per NIN recommendation (50% to 60%) - Above NIN recommendation (\> 60%)

Time frame: baseline and 16 weeks

Secondary Outcomes

Mean change of HbA1c

Time frame: Baseline and 16 weeks

Mean change of fasting blood glucose(FBG)

Time frame: Base line and 16 weeks

Mean change of low density lipoprotein cholesterol(LDL)

Time frame: baseline and 16 weeks

Mean change of high density lipoprotein cholesterol(HDL)

Time frame: Baseline and 16 weeks

Mean change of total cholesterol(TC)

Time frame: baseline and 16 weeks

Mean change of Body weight

Time frame: baseline and 16 weeks

Mean change of triglyceride(TG)

Time frame: baseline and 16 weeks

Compare the mean change between acarbose and metformin arm of postprandial blood glucose (PPBG)

Time frame: baseline and 16 weeks

Compare the mean change between acarbose and metformin arm of HbA1c

Time frame: baseline and 16 weeks

Compare the mean change between acarbose and metformin arm of FBG

Time frame: baseline and 16 weeks

Compare the mean change between acarbose and metformin arm of LDL

Time frame: baseline and 16 weeks

Compare the mean change between acarbose and metformin arm of HDL

Time frame: baseline and 16 weeks

Compare the mean change between acarbose and metformin arm of TC

Time frame: baseline and 16 weeks

Compare the mean change between acarbose and metformin arm of TG

Time frame: baseline and 16 weeks

Compare the mean change between acarbose and metformin arm of Body weight

Time frame: baseline and 16 weeks

Change in gastrointestinal tolerability to therapy from post baseline visit to the end of observation period of up to 16 weeks

Time frame: baseline and 16 weeks

Incidence rate of adverse drug reactions in acarbose and metformin treated groups during 16 weeks observation period

Time frame: 16 weeks